BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HORIZON MEDICAL IMAGING

    MDR report key: 937082 · Received October 31, 2007

    Report

    Report Number
    8022257-2007-00003
    Event Type
    Malfunction
    Date Received
    October 31, 2007
    Date of Event
    June 13, 2007
    Report Date
    October 31, 2007
    Manufacturer
    MCKESSON MEDICAL IMAGING COMPANY
    Product Code
    LLZ
    PMA / PMN Number
    K043146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MCKESSON MEDICAL IMAGING COMPANY DETERMINED THAT NON-STANDARD CONFIGURATION SETTINGS ON THE LEGACY PACS AND HORIZON MEDICAL IMAGING (HMI) AT SPECTRUM HEALTH CONTRIBUTED TO THE REPORTED PROBLEM. THE PROBLEM WAS RESOLVED BY RETURNING THE PARTICULAR CONFIGURATION VARIABLES TO THEIR DEFAULT SETTINGS. IT WAS DETERMINED THAT THE HMI SYSTEM AT SPECTRUM HEALTH WAS THE ONLY CUSTOMER WHICH HAD CONFIGURATION SETTINGS THAT WOULD GIVE RISE TO THE REPORTED PROBLEM.

    Description of Event or Problem · 1

    SOME STUDIES STORED ONLINE IN MEDICAL IMAGING FROM DICOM PUSH IMPORT FROM A CUSTOMER'S LEGACY PACS, WHICH HAD NON-STANDARD CONFIGURATION SETTINGS, MAY BE ASSOCIATED WITH AN INCORRECT PATIENT AND MISIDENTIFIED AS BELONGING TO THAT PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HORIZON MEDICAL IMAGING PICTURE ARCHIVING AND COMMUNICATION SYS. LLZ MCKESSON MEDICAL IMAGING COMPANY HMI 11.0

    Patients

    Seq Age Sex Outcome Treatment
    1 YR